An interventional study of Soterix 1x1 tDCS mini-CT Stimulator device in Knee Osteoarthritis and Chronic Pain, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-10-15.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment
The purpose of this study is to determine the feasibility and preliminary efficacy of two weeks of self Transcranial Direct Current Stimulation (tDCS) for pain in older patients with knee osteoarthritis (OA).
Exclusion Criteria:
Transcranial Direct Current Stimulation (tDCS) involves the application of weak direct electric current to the head in a noninvasive and painless manner. tDCS with a constant current intensity of 2 milliamps (mA) will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device. Participants will self-administer tDCS at their home or a private room for two weeks (Mondays-Fridays) under real-time supervision by the research staff.
Device: Soterix 1x1 tDCS mini-CT Stimulator device
Transcranial Direct Current Stimulation (tDCS) involves the application of weak direct electric current to the head in a noninvasive and painless manner. tDCS with a constant current intensity of 2 mA will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device. Participants will self-administer tDCS at their home or a private room for two weeks (Mondays-Fridays) under real-time supervision by the research staff.
Clinical Pain Intensity as Assessed by a Visual Analogue Scale (VAS)
Scores on the visual analogue scale (VAS) range from 0 (no pain) to 100 (worst pain imaginable).
Time frame: baseline
Clinical Pain Intensity as Assessed by a Visual Analogue Scale (VAS)
Scores on the visual analogue scale (VAS) range from 0 (no pain) to 100 (worst pain imaginable).
Time frame: 2 weeks
Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Subscale
The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively.
Time frame: baseline
Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Subscale
The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively.
Time frame: 2 weeks
Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Stiffness Subscale
The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively.
Time frame: baseline
Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Stiffness Subscale
The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively.
Time frame: 2 weeks
Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Functional Impairment Subscale
The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively.
Time frame: baseline
Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Functional Impairment Subscale
The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively.
Time frame: 2 weeks
Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Continuous Pain Summary Scale
The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = "none" to 10 = "worst possible"). The continuous pain subscale assesses throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender, and total score on the continuous pain subscale ranges from 0-60, with a higher score indicating worse pain.
Time frame: baseline
Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Continuous Pain Subscale
The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = "none" to 10 = "worst possible"). The continuous pain subscale assesses throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender, and total score on the continuous pain subscale ranges from 0-60, with a higher score indicating worse pain.
Time frame: 2 weeks
Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Intermittent Pain Subscale
The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = "none" to 10 = "worst possible"). The intermittent pain subscale assesses shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing, and total score on the intermittent pain subscale ranges from 0-60, with a higher score indicating worse pain.
Time frame: baseline
Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Intermittent Pain Subscale
The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = "none" to 10 = "worst possible"). The intermittent pain subscale assesses shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing, and total score on the intermittent pain subscale ranges from 0-60, with a higher score indicating worse pain.
Time frame: 2 weeks
Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Neuropathic Pain Subscale
The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = "none" to 10 = "worst possible"). The neuropathic pain subscale assesses hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or 'pins and needles', and numbness, and total score on the neuropathic pain subscale ranges from 0-60, with a higher score indicating worse pain.
Time frame: baseline
Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Neuropathic Pain Subscale
The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = "none" to 10 = "worst possible"). The neuropathic pain subscale assesses hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or 'pins and needles', and numbness, and total score on the neuropathic pain subscale ranges from 0-60, with a higher score indicating worse pain.
Time frame: 2 weeks
Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Affective Description Subscale
The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = "none" to 10 = "worst possible"). The affective description subscale assesses tiring-exhausting, sickening, fearful, and punishing-cruel, and total score on the affective description subscale ranges from 0-40, with a higher score indicating worse pain.
Time frame: baseline
Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Affective Description Subscale
The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = "none" to 10 = "worst possible"). The affective description subscale assesses tiring-exhausting, sickening, fearful, and punishing-cruel, and total score on the affective description subscale ranges from 0-40, with a higher score indicating worse pain.
Time frame: 2 weeks
Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Threshold (HPTH)
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess HPTH, heat stimuli were delivered to the participant's arm or knee using a computer-controlled TSAII NeuroSensory Analyzer. From a baseline of 32 degrees Celsius, the temperature increased by 0.5 degrees Celsius per second until the participants responded by pressing a button to stop heat stimuli. Participants were instructed to press the button when the sensation ''first becomes painful" to assess the heat pain threshold (HPTH). The temperature at which participants pressed the button to indicate the sensation ''first becomes painful" is reported.
Time frame: baseline
Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Threshold (HPTH)
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess HPTH, heat stimuli were delivered to the participant's arm or knee using a computer-controlled TSAII NeuroSensory Analyzer. From a baseline of 32 degrees Celsius, the temperature increased by 0.5 degrees Celsius per second until the participants responded by pressing a button to stop heat stimuli. Participants were instructed to press the button when the sensation ''first becomes painful" to assess the heat pain threshold (HPTH). The temperature at which participants pressed the button to indicate the sensation ''first becomes painful" is reported.
Time frame: 2 weeks
Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Tolerance (HPTO)
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess HPTO, heat stimuli were delivered to the participant's arm or knee using a computer-controlled TSAII NeuroSensory Analyzer. From a baseline of 32 degrees Celsius, the temperature increased by 0.5 degrees Celsius per second until the participants responded by pressing a button to stop heat stimuli. Participants were instructed to press the button when they ''no longer feel able to tolerate the pain." The temperature at which participants pressed the button to indicate they could ''no longer feel able to tolerate the pain" is reported.
Time frame: baseline
Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Tolerance (HPTO)
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess HPTO, heat stimuli were delivered to the participant's arm or knee using a computer-controlled TSAII NeuroSensory Analyzer. From a baseline of 32 degrees Celsius, the temperature increased by 0.5 degrees Celsius per second until the participants responded by pressing a button to stop heat stimuli. Participants were instructed to press the button when they ''no longer feel able to tolerate the pain." The temperature at which participants pressed the button to indicate they could ''no longer feel able to tolerate the pain" is reported.
Time frame: 2 weeks
Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm\^2) per second to the participant's medial knee, lateral knee, or trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful." The pressure at which participants pressed the button to indicate that the pressure sensation ''first becomes painful" is reported.
Time frame: baseline
Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm\^2) per second to the participant's medial knee, lateral knee, or trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful." The pressure at which participants pressed the button to indicate that the pressure sensation ''first becomes painful" is reported.
Time frame: 2 weeks
Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Punctate Mechanical Pain (PMP)
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess PMP, punctate mechanical pain is delivered to the patella or hand by a calibrated nylon monofilament for 10 contacts of the monofilament at one contact per second. Participants rate the pain intensity on a scale from 0 (no pain) to 100 (maximum imaginable pain).
Time frame: baseline
Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Punctate Mechanical Pain (PMP)
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess PMP, punctate mechanical pain is delivered to the patella or hand by a calibrated nylon monofilament for 10 contacts of the monofilament at one contact per second. Participants rate the pain intensity on a scale from 0 (no pain) to 100 (maximum imaginable pain).
Time frame: 2 weeks
Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM)
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). CPM is reported as the change in PPT before and immediately following immersion of the contralateral hand up to the wrist in a cold water bath (12 degrees Celsius) for up to one minute. To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm\^2) per second to the participant's trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful." The pressure at which participants pressed the button to indicate that the pressure sensation ''first becomes painful" is reported.
Time frame: baseline
Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM)
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). CPM is reported as the change in PPT before and immediately following immersion of the contralateral hand up to the wrist in a cold water bath (12 degrees Celsius) for up to one minute. To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm\^2) per second to the participant's trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful." The pressure at which participants pressed the button to indicate that the pressure sensation ''first becomes painful" is reported.
Time frame: 2 weeks
Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy (fNIRS)
Pain-related cortical response will be measured using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) with three semiconductor lasers at 780, 805, and 830 nm. Optical recordings will be collected during thermal pain stimulation.
Time frame: 2 weeks
Feasibility as Assessed by a Survey of Participants' tDCS Experience - Ease of Using Device
Data will be collected on participants' tDCS experience at the conclusion of tDCS treatment on a scale of 0 (strongly disagree) to 10 (strongly agree): Q1) "Overall the device was easy to use"
Time frame: 2 weeks
Feasibility as Assessed by a Survey of Participants' tDCS Experience - Ease of Preparation of Device
Data will be collected on participants' tDCS experience at the conclusion of tDCS treatment on a scale of 0 (strongly disagree) to 10 (strongly agree): Q2) "It was easy to prepare the device and accessories"
Time frame: 2 weeks
Feasibility as Assessed by a Survey of Participants' tDCS Experience - Effectiveness of Treatment Over Time
Data will be collected on participants' tDCS experience at the conclusion of tDCS treatment on a scale of 0 (strongly disagree) to 10 (strongly agree): Q3) "The effectiveness of the treatment increased over the course of treatment."
Time frame: 2 weeks
Tolerability as Assessed by Number of Participants With Side Effects
The participants will be asked in an open-ended manner whether they have experienced any side effects, and they will then be asked specifically about tingling, itching sensation, burning sensation, pain at the stimulation site, fatigue, nervousness, headache, difficulty concentrating, mood change, and changes in vision or visual perception.
Time frame: 2 weeks
Anxiety as Assessed by the PROMIS Anxiety-short Form
The 7-item PROMIS anxiety-short form assesses the pure domain of anxiety in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety.
Time frame: baseline
Anxiety as Assessed by the PROMIS Anxiety-short Form
The 7-item PROMIS anxiety-short form assesses the pure domain of anxiety in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety.
Time frame: 2 weeks
Depression as Assessed by the PROMIS Depression-short Form
The 8-item PROMIS depression-short form assesses the pure domain of depression in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.
Time frame: baseline
Depression as Assessed by the PROMIS Depression-short Form
The 8-item PROMIS depression-short form assesses the pure domain of depression in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.
Time frame: 2 weeks
Sleep Disturbance as Assessed by the PROMIS Sleep Disturbance-short Form
The 8-item PROMIS sleep disturbance-short form assesses the pure domain of sleep disturbance in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
Time frame: baseline
Sleep Disturbance as Assessed by the PROMIS Sleep Disturbance-short Form
The 8-item PROMIS sleep disturbance-short form assesses the pure domain of sleep disturbance in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
Time frame: 2 weeks
| Milestone | Transcranial Direct Current Stimulation |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
Scores on the visual analogue scale (VAS) range from 0 (no pain) to 100 (worst pain imaginable).
| units on a scale | Transcranial Direct Current Stimulation |
|---|---|
| Clinical Pain Intensity as Assessed by a Visual Analogue Scale (VAS) | 55.23 ± 25.45 |
Scores on the visual analogue scale (VAS) range from 0 (no pain) to 100 (worst pain imaginable).
| units on a scale | Transcranial Direct Current Stimulation |
|---|---|
| Clinical Pain Intensity as Assessed by a Visual Analogue Scale (VAS) | 24.85 ± 22.70 |
The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively.
| score on a scale | Transcranial Direct Current Stimulation |
|---|---|
| Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Subscale | 7.95 ± 4.39 |
The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively.
| units on a scale | Transcranial Direct Current Stimulation |
|---|---|
| Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Subscale | 5.75 ± 4.25 |
The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively.
| units on a scale | Transcranial Direct Current Stimulation |
|---|---|
| Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Stiffness Subscale | 4.00 ± 1.86 |
The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively.
| units on a scale | Transcranial Direct Current Stimulation |
|---|---|
| Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Stiffness Subscale | 2.90 ± 1.74 |
The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively.
| units on a scale | Transcranial Direct Current Stimulation |
|---|---|
| Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Functional Impairment Subscale | 29.10 ± 17.53 |
The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively.
| units on a scale | Transcranial Direct Current Stimulation |
|---|---|
| Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Functional Impairment Subscale | 20.85 ± 15.22 |
The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = "none" to 10 = "worst possible"). The continuous pain subscale assesses throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender, and total score on the continuous pain subscale ranges from 0-60, with a higher score indicating worse pain.
| units on a scale | Transcranial Direct Current Stimulation |
|---|---|
| Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Continuous Pain Summary Scale | 22.75 ± 15.26 |
The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = "none" to 10 = "worst possible"). The continuous pain subscale assesses throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender, and total score on the continuous pain subscale ranges from 0-60, with a higher score indicating worse pain.
| units on a scale | Transcranial Direct Current Stimulation |
|---|---|
| Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Continuous Pain Subscale | 14.05 ± 13.84 |
The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = "none" to 10 = "worst possible"). The intermittent pain subscale assesses shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing, and total score on the intermittent pain subscale ranges from 0-60, with a higher score indicating worse pain.
| units on a scale | Transcranial Direct Current Stimulation |
|---|---|
| Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Intermittent Pain Subscale | 17.80 ± 16.18 |
The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = "none" to 10 = "worst possible"). The intermittent pain subscale assesses shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing, and total score on the intermittent pain subscale ranges from 0-60, with a higher score indicating worse pain.
| units on a scale | Transcranial Direct Current Stimulation |
|---|---|
| Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Intermittent Pain Subscale | 12.90 ± 15.80 |
The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = "none" to 10 = "worst possible"). The neuropathic pain subscale assesses hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or 'pins and needles', and numbness, and total score on the neuropathic pain subscale ranges from 0-60, with a higher score indicating worse pain.
| units on a scale | Transcranial Direct Current Stimulation |
|---|---|
| Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Neuropathic Pain Subscale | 11.1 ± 13.71 |
The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = "none" to 10 = "worst possible"). The neuropathic pain subscale assesses hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or 'pins and needles', and numbness, and total score on the neuropathic pain subscale ranges from 0-60, with a higher score indicating worse pain.
| units on a scale | Transcranial Direct Current Stimulation |
|---|---|
| Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Neuropathic Pain Subscale | 8.2 ± 14.23 |
The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = "none" to 10 = "worst possible"). The affective description subscale assesses tiring-exhausting, sickening, fearful, and punishing-cruel, and total score on the affective description subscale ranges from 0-40, with a higher score indicating worse pain.
| units on a scale | Transcranial Direct Current Stimulation |
|---|---|
| Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Affective Description Subscale | 11.7 ± 11.65 |
The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = "none" to 10 = "worst possible"). The affective description subscale assesses tiring-exhausting, sickening, fearful, and punishing-cruel, and total score on the affective description subscale ranges from 0-40, with a higher score indicating worse pain.
| units on a scale | Transcranial Direct Current Stimulation |
|---|---|
| Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Affective Description Subscale | 5.75 ± 10.40 |
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess HPTH, heat stimuli were delivered to the participant's arm or knee using a computer-controlled TSAII NeuroSensory Analyzer. From a baseline of 32 degrees Celsius, the temperature increased by 0.5 degrees Celsius per second until the participants responded by pressing a button to stop heat stimuli. Participants were instructed to press the button when the sensation ''first becomes painful" to assess the heat pain threshold (HPTH). The temperature at which participants pressed the button to indicate the sensation ''first becomes painful" is reported.
| degrees Celsius | Transcranial Direct Current Stimulation |
|---|---|
| arm | 37.9 ± 3.3 |
| knee | 39.1 ± 3.5 |
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess HPTH, heat stimuli were delivered to the participant's arm or knee using a computer-controlled TSAII NeuroSensory Analyzer. From a baseline of 32 degrees Celsius, the temperature increased by 0.5 degrees Celsius per second until the participants responded by pressing a button to stop heat stimuli. Participants were instructed to press the button when the sensation ''first becomes painful" to assess the heat pain threshold (HPTH). The temperature at which participants pressed the button to indicate the sensation ''first becomes painful" is reported.
| degrees Celsius | Transcranial Direct Current Stimulation |
|---|---|
| arm | 37.3 ± 2.0 |
| knee | 40.1 ± 3.4 |
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess HPTO, heat stimuli were delivered to the participant's arm or knee using a computer-controlled TSAII NeuroSensory Analyzer. From a baseline of 32 degrees Celsius, the temperature increased by 0.5 degrees Celsius per second until the participants responded by pressing a button to stop heat stimuli. Participants were instructed to press the button when they ''no longer feel able to tolerate the pain." The temperature at which participants pressed the button to indicate they could ''no longer feel able to tolerate the pain" is reported.
| degrees Celsius | Transcranial Direct Current Stimulation |
|---|---|
| arm | 43.2 ± 3.1 |
| knee | 43.1 ± 3.3 |
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess HPTO, heat stimuli were delivered to the participant's arm or knee using a computer-controlled TSAII NeuroSensory Analyzer. From a baseline of 32 degrees Celsius, the temperature increased by 0.5 degrees Celsius per second until the participants responded by pressing a button to stop heat stimuli. Participants were instructed to press the button when they ''no longer feel able to tolerate the pain." The temperature at which participants pressed the button to indicate they could ''no longer feel able to tolerate the pain" is reported.
| degrees Celsius | Transcranial Direct Current Stimulation |
|---|---|
| arm | 43.2 ± 3.2 |
| knee | 44.6 ± 3.1 |
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm\^2) per second to the participant's medial knee, lateral knee, or trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful." The pressure at which participants pressed the button to indicate that the pressure sensation ''first becomes painful" is reported.
| kilograms force (kgf) | Transcranial Direct Current Stimulation |
|---|---|
| medial knee | 3.2 ± 1.4 |
| lateral knee | 3.5 ± 1.5 |
| trapezius | 2.9 ± 1.6 |
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm\^2) per second to the participant's medial knee, lateral knee, or trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful." The pressure at which participants pressed the button to indicate that the pressure sensation ''first becomes painful" is reported.
| kilograms force (kgf) | Transcranial Direct Current Stimulation |
|---|---|
| medial knee | 3.7 ± 1.2 |
| lateral knee | 4.4 ± 1.3 |
| trapezius | 3.9 ± 1.3 |
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess PMP, punctate mechanical pain is delivered to the patella or hand by a calibrated nylon monofilament for 10 contacts of the monofilament at one contact per second. Participants rate the pain intensity on a scale from 0 (no pain) to 100 (maximum imaginable pain).
| score on a scale | Transcranial Direct Current Stimulation |
|---|---|
| patella | 84.7 ± 23.4 |
| hand | 66.0 ± 27.0 |
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess PMP, punctate mechanical pain is delivered to the patella or hand by a calibrated nylon monofilament for 10 contacts of the monofilament at one contact per second. Participants rate the pain intensity on a scale from 0 (no pain) to 100 (maximum imaginable pain).
| score on a scale | Transcranial Direct Current Stimulation |
|---|---|
| patella | 67.4 ± 26.9 |
| hand | 54.6 ± 23.9 |
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). CPM is reported as the change in PPT before and immediately following immersion of the contralateral hand up to the wrist in a cold water bath (12 degrees Celsius) for up to one minute. To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm\^2) per second to the participant's trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful." The pressure at which participants pressed the button to indicate that the pressure sensation ''first becomes painful" is reported.
| kilograms force (kgf) | Transcranial Direct Current Stimulation |
|---|---|
| Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM) | 0.9 ± 0.7 |
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). CPM is reported as the change in PPT before and immediately following immersion of the contralateral hand up to the wrist in a cold water bath (12 degrees Celsius) for up to one minute. To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm\^2) per second to the participant's trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful." The pressure at which participants pressed the button to indicate that the pressure sensation ''first becomes painful" is reported.
| kilograms force (kgf) | Transcranial Direct Current Stimulation |
|---|---|
| Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM) | 1.3 ± 0.6 |
Pain-related cortical response will be measured using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) with three semiconductor lasers at 780, 805, and 830 nm. Optical recordings will be collected during thermal pain stimulation.
| Participants | Transcranial Direct Current Stimulation |
|---|---|
| Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy (fNIRS) | 20 |
Data will be collected on participants' tDCS experience at the conclusion of tDCS treatment on a scale of 0 (strongly disagree) to 10 (strongly agree): Q1) "Overall the device was easy to use"
| score on a scale | Transcranial Direct Current Stimulation |
|---|---|
| Feasibility as Assessed by a Survey of Participants' tDCS Experience - Ease of Using Device | 9.75 ± 0.44 |
Data will be collected on participants' tDCS experience at the conclusion of tDCS treatment on a scale of 0 (strongly disagree) to 10 (strongly agree): Q2) "It was easy to prepare the device and accessories"
| score on a scale | Transcranial Direct Current Stimulation |
|---|---|
| Feasibility as Assessed by a Survey of Participants' tDCS Experience - Ease of Preparation of Device | 9.75 ± 0.44 |
Data will be collected on participants' tDCS experience at the conclusion of tDCS treatment on a scale of 0 (strongly disagree) to 10 (strongly agree): Q3) "The effectiveness of the treatment increased over the course of treatment."
| score on a scale | Transcranial Direct Current Stimulation |
|---|---|
| Feasibility as Assessed by a Survey of Participants' tDCS Experience - Effectiveness of Treatment Over Time | 6.75 ± 3.17 |
The participants will be asked in an open-ended manner whether they have experienced any side effects, and they will then be asked specifically about tingling, itching sensation, burning sensation, pain at the stimulation site, fatigue, nervousness, headache, difficulty concentrating, mood change, and changes in vision or visual perception.
| Participants | Transcranial Direct Current Stimulation |
|---|---|
| Tolerability as Assessed by Number of Participants With Side Effects | 0 |
The 7-item PROMIS anxiety-short form assesses the pure domain of anxiety in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety.
| score on a scale | Transcranial Direct Current Stimulation |
|---|---|
| Anxiety as Assessed by the PROMIS Anxiety-short Form | 13.6 ± 6.73 |
The 7-item PROMIS anxiety-short form assesses the pure domain of anxiety in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety.
| score on a scale | Transcranial Direct Current Stimulation |
|---|---|
| Anxiety as Assessed by the PROMIS Anxiety-short Form | 12.05 ± 6.86 |
The 8-item PROMIS depression-short form assesses the pure domain of depression in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.
| units on a scale | Transcranial Direct Current Stimulation |
|---|---|
| Depression as Assessed by the PROMIS Depression-short Form | 12.3 ± 7.69 |
The 8-item PROMIS depression-short form assesses the pure domain of depression in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.
| units on a scale | Transcranial Direct Current Stimulation |
|---|---|
| Depression as Assessed by the PROMIS Depression-short Form | 11.85 ± 6.98 |
The 8-item PROMIS sleep disturbance-short form assesses the pure domain of sleep disturbance in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
| units on a scale | Transcranial Direct Current Stimulation |
|---|---|
| Sleep Disturbance as Assessed by the PROMIS Sleep Disturbance-short Form | 24.3 ± 7.87 |
The 8-item PROMIS sleep disturbance-short form assesses the pure domain of sleep disturbance in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
| units on a scale | Transcranial Direct Current Stimulation |
|---|---|
| Sleep Disturbance as Assessed by the PROMIS Sleep Disturbance-short Form | 19.85 ± 8.10 |
Collected over 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Transcranial Direct Current Stimulation | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Transcranial Direct Current Stimulation |
|---|---|
| Mean | 61.2 ± 7.23 |
| Sex: Female, Male(Participants) | Transcranial Direct Current Stimulation |
|---|---|
| Female | 15 |
| Male | 5 |
| Race/Ethnicity, Customized(Participants) | Transcranial Direct Current Stimulation |
|---|---|
| African American | 6 |
| Asian | 6 |
| Hispanic | 1 |
| White | 7 |
| Region of Enrollment(Participants) | Transcranial Direct Current Stimulation |
|---|---|
| United States | 20 |
| Education(Participants) | Transcranial Direct Current Stimulation |
|---|---|
| High School | 3 |
| 2-year college | 5 |
| 4-year college | 9 |
| Master's degree | 2 |
| Doctoral degree | 1 |
| Body Mass Index (BMI)(kg/m^2) | Transcranial Direct Current Stimulation |
|---|---|
| Mean | 28.33 ± 8.01 |
| Osteoarthritis duration(months) | Transcranial Direct Current Stimulation |
|---|---|
| Mean | 29.60 ± 26.17 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The University of Texas Health Science Center, Houston